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Immunotherapy Using Pluripotent Killer-Human Epidermal Growth Factor Receptor-2 (PIK-HER2) Cells for the Treatment of Advanced Gastric Cancer With Liver Metastasis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02632201
Recruitment Status : Unknown
Verified September 2015 by Second Military Medical University.
Recruitment status was:  Recruiting
First Posted : December 16, 2015
Last Update Posted : January 1, 2016
Sponsor:
Information provided by (Responsible Party):
Second Military Medical University

Brief Summary:

Objectives:

The purpose of this study is to evaluate the safety and efficacy of PIK-HER2 cells in the treatment of advanced Her2 high expressed gastric cancer with liver metastasis patients.

Methods:

This study designs a novel therapy using PIK-HER2 cells. 40 Her2 positive patients with liver metastasis from gastric cancer will be enrolled. They are randomly divided into dendritic cell-precision multiple antigen T cells (DC-PMAT) group and PIK-HER2 cells group. Both DC-PMAT treatment and PIK-HER2 cells treatment will be performed every 3 weeks with a total of three periods. The mail clinical indicators are Progression-Free-Survival and Overall Survival.


Condition or disease Intervention/treatment Phase
Liver Metastasis Gastric Cancer Biological: PIK-HER2 Biological: DC-PMAT Phase 1 Phase 2

Detailed Description:
A total of 40 patients may be enrolled over a period of 1-2 years.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Clinical Study of Adoptive Cellular Immunotherapy Using Pluripotent Killer T Cells Expressing Antibodies for Human Epidermal Growth Factor Receptor-2 (HER2) in Treating Patients With HER2-Positive Advanced Gastric Cancer With Liver Metastasis
Study Start Date : September 2015
Estimated Primary Completion Date : March 2017
Estimated Study Completion Date : September 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Stomach Cancer

Arm Intervention/treatment
Experimental: PIK-HER2 cells
PIK-HER2 cells treatment will be performed every 3 weeks with a total of three periods.
Biological: PIK-HER2
DC cell suspension (1×107 DC+ physiological saline + 0.25% human serum albumin) 1ml for each infusion, subcutaneous injection for each infusion 3 cycles, each cycle received two infusions on day 19, 20; 40, 41; 61, 62. PIK-HER2 cell suspension (1-6×109 PIK-HER2 + physiological saline + 0.25% human serum albumin) 300ml for each infusion, IV (in the vein) for each infusion 3 cycles, each cycle received one infusions on day 21, 42, 63.

Active Comparator: DC-PMAT
DC-PMAT treatment will be performed every 3 weeks with a total of three periods.
Biological: DC-PMAT
DC cell suspension (1×107 DC+ physiological saline + 0.25% human serum albumin) 1ml for each infusion, subcutaneous injection for each infusion 3 cycles, each cycle received two infusions on day 19, 20; 40, 41; 61, 62. PMAT cell suspension (1-6×109 PMAT + physiological saline + 0.25% human serum albumin) 300ml for each infusion, IV (in the vein) for each infusion 3 cycles, each cycle received one infusions on day 21, 42, 63.




Primary Outcome Measures :
  1. Overall survival [ Time Frame: 2 years ]

Secondary Outcome Measures :
  1. Progress-free survival [ Time Frame: 2 years ]
  2. Quality of life [ Time Frame: 2 years ]
    Quality of life core questionnaire will be used.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age 18~65 years old, male or female
  2. Life expectancy > 6 months
  3. Eastern Cooperative Oncology Group (ECOG) score: 0-2
  4. The stomach or gastroesophageal junction carcinoma with hepatic metastasis
  5. Adenocarcinoma
  6. The expression of HER2 in immunohistochemical tumor tissue should be greater than or equal to 2 levels
  7. Creatinine is less than 2.5mg/dL; alanine aminotransferase (ALT) / aspartate aminotransferase(AST)T less than 3 times of the normal; bilirubin is less than 3mg/dL
  8. Blood routine conforms to the requirements of the blood sampling
  9. Signed informed consent
  10. Patients with fertility are willing to use contraceptive method.

Exclusion Criteria:

  1. Expected Overall survival < 6 months
  2. Other serious diseases:the heart,lung,kidney, digestive, nervous, mental disorders, immune regulatory diseases,metabolic diseases, infectious diseases, Etc.
  3. Serum creatinine > 2.5mg/dL;Serum Glutamic Oxaloacetic Transaminase (SGOT) > 5 times of the normal;total bilirubin > 100μmol/L
  4. Without signed informed consent.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02632201


Contacts
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Contact: Qijun Qian, PHD +86-21-65580677 qianqj@sino-gene.cn
Contact: Huajun Jin, PHD +86-21-81875372 hj-jin@Hotmail.com

Locations
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China
Eastern Hepatobiliary Surgery Hospital Recruiting
Shanghai, China, 200438
Contact: Huajun Jin, PHD    +86-21-81875372    hj-jin@hotmail.com   
Principal Investigator: Qijun Qian, PHD         
Principal Investigator: Huajun Jin, PHD         
Principal Investigator: Qian Zhang, MD         
Principal Investigator: Zhenlong Ye, PHD         
Sub-Investigator: Lingling Guo, MD         
Sub-Investigator: Yao Huang, MD         
Sponsors and Collaborators
Second Military Medical University
Investigators
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Study Chair: Qijun Qian, PHD Eastern Hepatobiliary Surgery Hospital
Publications:

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Responsible Party: Second Military Medical University
ClinicalTrials.gov Identifier: NCT02632201    
Other Study ID Numbers: EHBHKY2015-02-008
First Posted: December 16, 2015    Key Record Dates
Last Update Posted: January 1, 2016
Last Verified: September 2015
Keywords provided by Second Military Medical University:
gastric cancer
liver metastasis
PIK-HER2 cells
dendritic cell-precision multiple antigen T cells
Additional relevant MeSH terms:
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Neoplasm Metastasis
Neoplasms, Second Primary
Stomach Neoplasms
Liver Neoplasms
Neoplastic Processes
Neoplasms
Pathologic Processes
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Liver Diseases